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| Name | Class |
|---|---|
| Advanced Accelerator Applications | INDUSTRY |
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Gallium-68 DOTATATE is a radioactive tracer, a type of imaging drug that is labeled with a radioactive tag and injected into the body, which is approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors. The study will see how the tracer is taken up in your heart before and after treatment using an imaging scan called Positron Emission Tomography / Computed Tomography (PET/CT). Investigators are doing this research study to find out if DOTATATE can help doctors diagnose people with cardiac (heart) sarcoidosis better as well as serve as a follow-up monitoring tool for a response to therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Suspected Cardiac Sarcoidosis | patients with biopsy proven or suspected sarcoidosis (based on standard clinical imaging findings). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gallium-68 DOTATATE | Drug | Gallium-68 DOTATATE is a radioactive tracer, a type of imaging drug that is labeled with a radioactive tag and injected into the body, which is approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors. |
| Measure | Description | Time Frame |
|---|---|---|
| Dotatate SUVmax activity in the heart | The standardized uptake value (SUV) is a nuclear medicine unit commonly used to distinguish between "normal" and "abnormal" levels of tissue uptake. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dotatate SUVmax activity in the heart on follow-up PET/CT scan compared to baseline | Dotatate activity (in SUVmax units) in the heart will be measured at baseline and then again at least 3 months after immunotherapy initiation in subjects with suspected cardiac sarcoidosis | 3 years |
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Inclusion Criteria:
Participants will be ≥ 18 years of age
History of biopsy-proven sarcoidosis OR suspected sarcoidosis based on standard clinical imaging (e.g. FDG PET/CT, MRI) without biopsy confirmation
Clinical suspicion of cardiac involvement defined as the presence of any of the following:
FDG PET/CT scan demonstrating abnormal myocardial FDG uptake
Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures
Exclusion Criteria:
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Patients with Suspected Cardiac Sarcoidosis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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